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Generated: May 22, 2019

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KYPROLIS Drug Profile

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Which patents cover Kyprolis, and what generic alternatives are available?

Kyprolis is a drug marketed by Onyx Therap and is included in one NDA. There are eleven patents protecting this drug and three Paragraph IV challenges.

This drug has two hundred and four patent family members in thirty-nine countries.

The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.

Drug patent expirations by year for KYPROLIS
Generic Entry Opportunity Date for KYPROLIS
Generic Entry Date for KYPROLIS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for KYPROLIS
Drug ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors
Synonyms for KYPROLIS
(2S)-4-methyl-N-[(2S)-1-[[(2S)-4-methyl-1-[(2R)-2-methyloxiran-2-yl]-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]-2-[[(2S)-2-[(2-morpholin-4-ylacetyl)amino]-4-phenylbutanoyl]amino]pentanamide
(2S)-N-((1S)-1-Benzyl-2-(((1S)-3-methyl-1-(((2R)-2-methyloxiran-2-yl)carbonyl)butyl)amino)-2-oxoethyl)-4-methyl-2-(((2S)-2-((morpholin-4-ylacetyl)amino)-4-phenylbutanoyl)amino)pentanamide
(2S)-N-[(1S)-1-benzyl-2-[[(1S)-3-methyl-1-[(2R)-2-methyloxirane-2-carbonyl]butyl]amino]-2-oxo-ethyl]-4-methyl-2-[[(2S)-2-[(2-morpholinoacetyl)amino]-4-phenyl-butanoyl]amino]pentanamide
(Alphas)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-l-leucyl-n-((1s)-3-methyl-1-(((2r)-2-methyloxiranyl)carbonyl)butyl)-l-phe nylalaninamide
(alphas)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-l-leucyl-n-((1s)-3-methyl-1-(((2r)-2-methyloxiranyl)carbonyl)butyl)-l-phenylalaninamide
(alphaS)-alpha-[[2-(4-Morpholinyl)acetyl]amino]benzenebutanoyl-L-leucyl-N-[(1S)-3-methyl-1-[[(2R)-2-methyl-2-oxiranyl]carbonyl]butyl]-L-phenylalaninamide
(S)-4-methyl-N-((S)-1-(((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-yl)amino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)pentanamide
(S)-4-Methyl-N-((S)-1-((S)-4-Methyl-1-((R)-2- Methyloxiran-2-yl)-1 -oxopentan-2-ylaMino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2-MorpholinoacetaMido)-4-phenylbutanaMido)pentanaMide
72X6E3J5AR
868540-17-4
AB0008111
AB01565867_02
AC-27051
AK546882
AKOS025401910
AN-217
AOB87759
AS-17059
BC251806
BDBM50277889
BLMPQMFVWMYDKT-NZTKNTHTSA-N
C40H57N5O7
Carfilzomib
Carfilzomib (JAN/USAN/INN)
Carfilzomib (PR-171)
Carfilzomib [USAN:INN]
Carfilzomib; PR171
Carfilzomib?PR-171?/Kyprolis
Carfilzomib(PR171)
CAS-868540-17-4
CHEBI:65347
CHEMBL451887
CS-0984
CS-W004540
D08880
DB08889
DSSTox_CID_28616
DSSTox_GSID_48690
DSSTox_RID_82886
DTXSID4048690
EX-A2037
FT-0696769
GTPL7420
HY-10455
J-501773
KB-75946
KS-00000SR1
Kyprolis (TN)
L-Phenylalaninamide, (alphaS)-alpha-((4-morpholinylacetyl)amino)benzenebutanoyl-L-leucyl-N-((1S)-3-methyl-1-(((2R)-2-methyloxiranyl)carbonyl)butyl)-
MLS006011102
MolPort-027-950-907
N-{(2S)-2-[(morpholin-4-ylacetyl)amino]-4-phenylbutanoyl}-L-leucyl-N-{(2S)-4-methyl-1-[(2R)-2-methyloxiran-2-yl]-1-oxopentan-2-yl}-L-phenylalaninamide
NCGC00249613-01
NCGC00249613-02
NCGC00249613-03
ONO-7057
PR-171
PX-171-007
QCR-96
RL05381
S-7798
s2853
SB16813
SC-91032
SCHEMBL85165
SMR004660024
SR-01000941582
SR-01000941582-1
SW218090-2
Tox21_113079
Tox21_113079_1
UNII-72X6E3J5AR
Y0441
ZINC49841054

US Patents and Regulatory Information for KYPROLIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for KYPROLIS
Drugname Dosage Strength RLD Date
➤ Subscribe For Injection 10 mg/vial ➤ Subscribe ➤ Sign Up
➤ Subscribe For Injection 30 mg/vial ➤ Subscribe ➤ Sign Up
➤ Subscribe For Injection 60 mg/vial ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for KYPROLIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1781688 C01781688/01 Switzerland ➤ Sign Up PRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: SWISSMEDIC 65690 23.11.2015
1781688 2016/013 Ireland ➤ Sign Up PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688 16C0017 France ➤ Sign Up PRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: EU/1/15/1060 20151123
1781688 122016000032 Germany ➤ Sign Up PRODUCT NAME: CARFILZOMIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1060 20151119
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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